LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPES

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED DIFFICULTY MAINTAINING A BATTERY CHARGE DURING REPROCESSING OF AN OLYMPUS BATTERY-POWERED ENDOSCOPIC LIGHT SOURCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.